study of sacituzumab govitecan (sg) in japanese participants with advanced solid tumors

Conditions: Advanced Solid Tumor; Metastatic Triple-Negative Breast Cancer; HR+/HER2- Metastatic Breast Cancer; Metastatic Urothelial Cancer

Summary: the primary objectives of this study are as follows: phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (sg) as a single agent and to determine the recommended phase 2 dose (rp2d) of sg in japanese participants with advance solid tumors. phase 2: evaluate the safety and efficacy of sg in japanese participants with metastatic triple-negative breast cancer (mtnbc), hormone receptor-positive (hr+)/human epidermal growth factor receptor 2-negative (her2-) metastatic breast cancer (mbc), and metastatic urothelial cancer (muc).


Eligibility criteria:
key inclusion criteria: * eastern cooperative oncology group (ecog) performance status ≤ 1 * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) as per recist version 1.1 criteria * adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation * adequate hepatic function (bilirubin ≤ 1.5 upper limit of normal (uln)), alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 uln * creatinine clearance ≥ 30 ml/min * male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * phase 1 only: histologically or cytologically confirmed advanced solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. * phase 2 metastatic triple-negative breast cancer (mtnbc) cohort: histologically or cytologically confirmed tnbc per american society of clinical oncologists/college of american pathologists (asco/cap) criteria, based on the most recent analyzed biopsy or other pathology specimen. refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer. * phase 2 hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (hr+/her2- mbc) cohort: documented evidence of hr+/her2- mbc confirmed by a local laboratory and defined per asco/cap criteria. * refractory to or relapsed after 2 prior systemic chemotherapy regimens for locally advanced unresectable or metastatic disease. * phase 2 metastatic urothelial cancer (muc) cohort: histologically documented uc that is metastatic or locally advanced unresectable. * progressed or recurred following receipt of platinum-containing regimen and anti-pd-1/pd-l1 therapy for metastatic or locally advanced unresectable disease key exclusion criteria: * positive serum pregnancy test, or females who may possibly be pregnant * known gilbert's disease * have previously received antibody drug conjugate containing topoisomerase i inhibitors * presence of bulky disease (defined as any single mass \> 7 cm in greatest dimension). * known to be hiv positive, or hepatitis b virus (hbv) surface antigen positive or hepatitis c virus (hcv) antibody positive at screening * known history of significant cardiac disease * known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness * history of interstitial lung disease * history of clinically significant gastrointestinal (gi) bleeding, have active chronic inflammatory bowel disease (ulcerative colitis, crohn's disease) or gi perforation * individuals with a history of anaphylactic reaction to irinotecan. note: other protocol defined inclusion/exclusion criteria may apply.